Children's Memorial Hospital
Chicago, Illinois, 60614, United States
NCT Number: NCT01559740
After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may experience some amount of pain in the post-operative period. As part of the anesthesia technique, the investigators routinely provide a nerve block done on the abdominal wall that will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP block. The purpose of this study is to determine if the nerve block performed with local anesthetic solution using a regular concentration solution vs. a diluted solution may offer different durations of pain relief.
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Notify MeUp to 8 year
All sexes
Interventional
Phase 2
Chicago, Illinois, 60614, United States
Children undergoing groin surgery or abdominal surgery under general anesthesia are offered pain relief postoperatively using regional anesthesia techniques including a central block like a caudal block, or peripheral nerve blocks including ultrasound guided ilioinguinal nerve block or transversus abdominis plane (TAP) block. The TAP block, a peripheral block of the thoraco-lumbar nerve roots as they exit between the internal oblique and the transversus abdominis muscle can be easily visualized using ultrasound guidance. The TAP block has been used for analgesia following major surgeries including lower abdominal surgeries and in newborn infants following major abdominal procedures including colostomy placement.1 The purpose of this study is to determine if two different concentrations of bupivacaine delivered at a total dose of 1 mL/kg offer similar or altered analgesia, i.e., does the concentration of the anesthetic matter more than the volume of local anesthetic while performing a TAP block in children undergoing groin surgery. Parents and the investigators will be blinded to the solution used for the TAP block. The solution will be drawn up by an investigator who is not a participant in the patient's care in a sterile fashion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is being used as the local anesthetic for the TAP blocks at either 0.25% or 0.125%. The block will be done once during the procedure.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
The difference in concentrations will be measured by using FLACC score every 5 mins for one hour after surgery in the Post Anesthesia Care Unit. Blood pressuer and heart rate will also be recorded.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
The dose of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the dose of pain medications administered in a caregiver questionnaire sheet.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
The number of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the number of pain medications administered in a caregiver questionnaire sheet.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
The time pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the time pain medications administered in a caregiver questionnaire sheet.
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control: Is it the Concentration or Volume of Local Anesthetic Solution That Improves Analgesia?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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